Efforts to Reregulate Nutritional Supplements Gain Momentum (June 1, 2004) The relative freedom that Americans have had to access a wide variety of nutritional supplements in recent years may be coming to an end. From a number of different directions, forces are moving forward quickly and seemingly inexorably to strengthen the government's regulation of nutritional supplements. The result will be that the ability of individuals to purchase and use supplements - vitamins, minerals, herbs, amino acids, and so on - freely and without excessive restrictions may soon be in jeopardy. The last time supplement freedom came under such a threat was in the early 1990s when legislation was introduced that would have expanded the Food and Drug Administration’s (FDA) enforcement powers and added tough new penalties to regulate the supplement industry. A groundswell of public comment and grassroots opposition directed at members of Congress, however, resulted in legislation more favorable to the industry and to consumer freedom being written, passed, and signed into law in 1994, the Dietary Supplement Health and Education Act (DSHEA). DSHEA established that supplements "are to be regulated like foods instead of drugs, meaning that they are considered safe unless proved otherwise and are not required to be clinically tested before they reach the market." Opponents of supplements and proponents of regulation have never given up the fight, however. In 2004, there are a lot of these people around. The following are among the developments that everyone who values personal freedom in this vital area needs to be concerned about. 1. On April 1, the Institute of Medicine (IOM), part of the prestigious and influential National Academy of Sciences (NAS), released a 370-page report, "forthcoming" in print (at a cost of $60), and currently available in a difficult to read online version. The report, titled Dietary Supplements: A Framework for Evaluating Safety, received extensive national media attention. Commissioned by the FDA, it was the result of three years' worth of work by a list of experts in the field. The IOM report, in plain English (according to the headline of one press account), says the "FDA Can Pull Supplements Without Proof." Another story highlights the report's conclusions: 'The Food and Drug Administration doesn't need direct evidence of human harm before taking steps to curb sales of a dietary supplement. . .Data from animals, test-tube studies, even similar products can suffice. . .The report promises to bolster new FDA efforts to crack down on risky supplements -- and challenges long-held assumptions that the agency must prove an ingredient unsafe before pulling it off the market." Among its many recommendations, the report calls on the Congress to increase funding for the FDA to oversee the supplement industry, including requiring manufacturers to report customers' side effects to the FDA. To do that, manufacturers would have to establish toll-free hot lines and publish the contact information on supplement bottle labels. Even more problematic and expensive for the industry would be a new requirement that manufacturers would need to provide the FDA with all information about a supplement before it is marketed. That data would include animal studies, laboratory tests, and other scientific information including data about products similar to the new supplement. The chairwoman of the committee that wrote the IOM report, Barbara O. Schneeman, a professor of nutrition at the University of California-Davis, was quoted widely in the media. Less than two weeks later, she was appointed to head the FDA's Office of Nutritional Products, Labeling and Dietary Supplements. The office is a component of the FDA's Center for Food Safety and Applied Nutrition. In December 2003 the FDA banned the nutritional supplement ephedra, notwithstanding the lack of any substantive issues with that particular substance. That ban represented the opening salvo in a new campaign to revise the 1994 DSHEA (Dietary Supplements Health and Education Act) and give greatly expanded powers to the government to re-regulate all nutritional and herbal supplements, taking decision-making and freedom to choose out of the hands of consumers. 2. In a striking and suspicious coincidence, the influential monthly magazine Consumer Reports on April 1 announced that its May issue would feature a cover story and several associated articles about the purported dangers of nutritional supplements. With its usual flair for attention-grabbing and high power PR, the magazine promoted one of the articles as exposing the “dirty dozen” of nutritional supplements. The Consumer Reports articles generated scores of reports in the mainstream media throughout May, for example “Dose of Danger,” a negative report broadcast by KOMO AM 1000 in Seattle on May 7. 3. On April 1, the same day that the IOM report was released, Sen. Dick Durbin (D-IL) gave a speech on the U.S. Senate floor. It was the latest salvo in his ongoing campaign in favor of enacting major new federal laws that expand the regulation of nutritional supplements. Durbin has made the anti-supplement agenda one of his core issues and highlights the cause at his official Web site under the banner of "consumer protection." He has introduced legislation, SB 722, that would significantly revise DSHEA and has influenced several other leading Democrat senators, including Hillary Clinton (D-NY), to join him as co-sponsors. Rep. Susan A. Davis (D-CA) has introduced similar legislation in the U.S. House of Representatives, HR 3377. Her Web site has a section that highlights her concerns about the supplement issues. At his Web site, Durbin denies that his bill would restrict Americans' access to nutritional supplements. Unlike the situation in the early 1990s, when citizen involvement and influence were unprecedented and definitive in turning back attempts to restrict supplement freedom, there is little analysis about or outcry today regarding what Durbin and other legislators are proposing. One group that has focused on supplement freedom is Citizens for Health (CFH), which got its start a decade ago during the vitamin wars of the early 1990s that culminated in DSHEA. At its Web site, CFH says: “Consumer response is urgently needed to ensure continued access to beneficial and safe dietary supplements. Take action right now and tell your Senators and Representative to support SB 1538, the DSHEA Full Implementation and Enforcement Act and to oppose SB 722, the so-called Dietary Supplement Safety Act. “Senate Bill 722, introduced last year by Senator Dick Durbin, has the support of leading Senators including John McCain, Hillary Clinton, Barbara Boxer and others. This bill potentially moves many safe products into an expensive drug model of regulation – a model requiring pre-approval of products prior to marketing. Take action today to protect our fundamental consumer right to access products that are safely used by millions.” CFH notes that “Momentum is building to severely undermine access to dietary supplements. Secretary of Health and Human Services, Tommy Thompson, is calling on Congress to rewrite and radically amend DSHEA. The inevitable result of such an action would mean severely curtailed access to vitamins, herbs and other supplements, along with substantially higher prices for those still on the market." To raise awareness of some of these issues in the House and Senate, particularly ones relating to herbal products, Citizens for Health is sponsoring an Herbal Alternatives briefing on Capitol Hill on June 17 by noted expert James Duke, PhD. As is often said in this space, stay tuned for developments.
|
